Lonza launches double-blinded capsules for trials
Capsugel DBcaps are designed to cover drugs during clinical trials, with a high degree of visual coverage and visual obstruction. They come in a range of sizes and colors, enabling them to be used in a variety of pharmaceutical products in different shapes and formats.
Lonza product manager Julien Lamps told Outsourcing-Pharma that the product is designed to overcome some of the difficulties associated with blinded trials.
“The main challenge in blinded clinical trials is to make sure that bias is avoided, meaning the enrolled patients and their care-givers shall not be able to distinguish one blinded form (the original or the placebo) from the one being tested, within and between the groups,” he explained. “Historically, this could have been achieved by adulterating the original form labelling, markings, or shapes but this raised then the question of the applicability of the study versus the effective use and mode of action for the original drug.”
The Capsugel DBcaps feature a tamper-evident design to enable testing without bias. According to Lamps, the broad size and color range means the products are suitable for over0encapsulation of more than 90% of marketed solid oral dosage forms.
The double layer design, with cap over body, reportedly makes the product extremely difficult to open. Two polymers are available: gelatin, and HPMC; both are designed to be readily set to an existing range of small-to-mid-size filling machines, what accelerates speed to clinic.
Lamps added that by offering a standard gelatin and HPMC version, the Capsugel DBcaps line is made suitable for use with multiple formulation properties. Also, the relatively short length is intended to make it easy for patients to swallow.
According to Stephen Rode, Lonza business development manager, said the products enable users to comply with necessary blinding requirements.
“During clinical trials it is imperative that sponsor companies and contract research companies alike can have peace of mind that they are complying sufficiently with blinding regulations to ensure a smooth journey to market,” he said. “By combining anti-tampering measures with a flexible and robust product, we have been able to develop a solution that will meet the needs of our customers globally.”